Tuesday, October 15, 2019

Very Brief Blog: FDA Releases Suite of Digital Guidances, including Clinical Decision Support

In late September 2019, FDA released a suite of guidance documents aimed to encourage the development of digital health tools and to continually modernize the agency's approach.

They were released with a statement from Amy Abernethy MD PhD, an oncologist with industry experience at Flatiron who is currently Principal Deputy Commissioner.

The detailed statement, with links to multiple new and existing agency documents, is online here.
  • One of the most important is a draft guidance on Clinical Decision Support - here.
    • Comments open for 90 days.
    • Summary at Ropes & Gray here.
    • Genomics tie-in:  CDS is considered important in genetics, precision medicine and oncology due to the tsunami of new facts.
  • See the 2017 FDA digital health plan white paper here.
  • FDA also finalizes changes to existing guidances based on 21st Century Cures Section 3060 - here.
  • FDA aims to harmonize where possible to the IMDRF - the International Medical Device Regulators Forum - here.
  • McDermott Will & Emery on the multiple FDA documents here.
Several existing guidances were also updated; see Abernethy's statement here.  These include the guidance for mobile applications, wellness devices, off-the-shelf software used in medical devices, and medical imaging software.


In December 2019, SCIENCE had an interesting article on FDA, artificial intelligence, algorithms, and "regulatory lockdown" by Babic et al. - here.